US6015387A - Implantation devices for monitoring and regulating blood flow - Google Patents
Implantation devices for monitoring and regulating blood flow Download PDFInfo
- Publication number
- US6015387A US6015387A US09/044,631 US4463198A US6015387A US 6015387 A US6015387 A US 6015387A US 4463198 A US4463198 A US 4463198A US 6015387 A US6015387 A US 6015387A
- Authority
- US
- United States
- Prior art keywords
- blood flow
- blood
- sensor circuit
- blood vessel
- electromagnetic signal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 230000017531 blood circulation Effects 0.000 title claims abstract description 68
- 238000002513 implantation Methods 0.000 title claims abstract description 7
- 238000012544 monitoring process Methods 0.000 title description 5
- 230000001105 regulatory effect Effects 0.000 title description 2
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 41
- 238000005259 measurement Methods 0.000 claims abstract description 13
- 238000000034 method Methods 0.000 claims description 15
- 239000013078 crystal Substances 0.000 claims description 11
- 239000003990 capacitor Substances 0.000 claims description 4
- 230000001225 therapeutic effect Effects 0.000 claims description 4
- 230000005684 electric field Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
- 239000008280 blood Substances 0.000 description 12
- 210000004369 blood Anatomy 0.000 description 12
- 239000000306 component Substances 0.000 description 7
- 238000012806 monitoring device Methods 0.000 description 5
- 230000008021 deposition Effects 0.000 description 3
- 230000004044 response Effects 0.000 description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000012503 blood component Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000003449 preventive effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6876—Blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
- A61B5/026—Measuring blood flow
- A61B5/0265—Measuring blood flow using electromagnetic means, e.g. electromagnetic flowmeter
- A61B5/027—Measuring blood flow using electromagnetic means, e.g. electromagnetic flowmeter using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6862—Stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/02—Operational features
- A61B2560/0204—Operational features of power management
- A61B2560/0214—Operational features of power management of power generation or supply
- A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
Definitions
- the current invention relates generally to devices and systems for monitoring and/or regulating blood flow in a blood vessel, and more particularly to devices and systems for measuring blood flow in a blood vessel in a non-invasive manner once the device has been implanted into or about the blood vessel.
- a number of blood flow measurements may be needed, over time, to effectively monitor the patient's condition.
- One known method of monitoring the flow in a blood vessel involves the percutaneous application of an instrument to measure the flow. Such methods are termed "invasive" in that the body must be pierced in order to measure the flow.
- invasive techniques to measure blood flow have a disadvantage in that the measurement must be taken under controlled conditions. For example, it becomes very difficult if not practically impossible to monitor blood flow during periods of increased exercise.
- a device that non-invasively measures the flow of blood in a blood vessel is desirous.
- Such a device would be implanted subcutaneously within the vessel as a stent, and activated by an external power source to measure the flow of blood in the vessel. It would be advantageous for the device to communicate with an external blood flow monitor to display the blood flow information. Since the measuring process is completely non-invasive, this technique permits monitoring of the blood flow under more extreme conditions for the patient, such as undergoing strenuous exercise or after given an appropriate drug.
- the present invention provides devices, and methods for measuring the flow of blood in a blood vessel in a non-invasive manner.
- a device in the form of a stent, graft or cuff is provided that is implanted in or around a blood vessel and that is powered externally to activate the taking of blood flow measurements .
- the results of the blood flow measurements are then displayed on a monitoring device.
- a hollow cylindrical device is provided that is suitable for implantation in or around a blood vessel of a patient.
- the device includes an electric circuit in the cavity of the cylinder that is powered externally to radiate transcutaneously an indication of the blood flow within the device.
- the electric circuit may be configured as a LC or RLC circuit, exhibiting resonance at a chosen frequency.
- a hollow cylindrical device is provided that is suitable for implantation in or around a blood vessel of a patient.
- the device includes a piezoelectric crystal for generating an ultrasonic wave that is directed toward the blood vessel.
- the same or a second piezoelectric crystal is employed to detect the reflected vibrational wave from the blood vessel and produce an RF signal that is indicative of blood flow within the blood vessel.
- the device is powered externally to radiate transcutaneously an indication of the blood flow within the device, and an external monitor is employed to calculate and display the blood flow results.
- the devices of the present invention can also provide a therapeutic function by applying heat or vibration to the blood to inhibit restenosis.
- a feed-back control loop regulates the therapeutic functions based on measurements of blood flow.
- FIG. 1 is a cross-sectional view of a device having an LC circuit enclosed therein for measuring blood flow in a blood vessel, in accordance with the current invention.
- FIG. 2 is an end view of a device using having one or more microchips surrounding the stent for measuring blood flow in a blood vessel, in accordance with the current invention.
- FIG. 3 is an end view of a device utilizing ultrasonic waves for measuring blood flow in a blood vessel, in accordance with the current invention.
- stent 100 is formed as a cylindrical, hollow tube of inert material suitable for implantation in a blood vessel of a patient.
- Stent 100 is open at both ends of the cylindrical tube to allow blood to flow through the stent.
- the outer diameter of the cylinder of stent 100 can be varied so as to fit within the blood vessel and to adapt to different blood vessel sizes.
- the length of the stent can be varied according to need.
- the wall of the cylinder is sufficiently thin so as to not to significantly restrict the blood flow through the stent.
- Stent 100 incorporates within the cylindrical cavity an electric circuit 110 that is activated to measure the blood flow of the patient.
- the blood flow measurements may be in the form of volume of flow/time or the velocity of the flow.
- electric circuit 110 is a LC circuit, having a coil 115 with inductance L and a capacitor 120 with capacitance C.
- the resistance R is a property of the wire, but may also be configured as a discrete component.
- Electric circuit 110 is fixedly attached to the cylindrical wall of stent 100, and positioned within the cylindrical tube of stent 100 so as to not appreciably impede blood flow through the device.
- Electric circuit 100 includes an antenna 125, serially connected to coil 115 and capacitance 120, for radiating an electromagnetic wave 135. Blood flowing through stent 100 acts as a dielectric for electric circuit 110.
- antenna 125 In response to an electromagnetic wave of energy 130 that is generated externally to the body and communicated through the skin to activate circuit 10, antenna 125 radiates a wave 135 that is indicative of the velocity or volume of flow/time of the blood flowing in stent 100.
- the electromagnetic wave of energy 130 may be a series of digital pulses or a sinusoidal wave that are transmitted transcutaneously to power electric circuit 110.
- the radiated wave 135 can be sensed by a monitoring device 140 which is exterior to the body, and the response converted to a blood flow measurement by monitoring device 140.
- an electromagnetic wave of energy 130 is generated at a frequency to cause electric circuit 110 to "ring" at its resonant frequency.
- a wire having a diameter of 0.0025 inches is used to create 10 layers of coils with each coil having 16 turns. It is found that to generate a resonant frequency of 100 MHz, a capacitance of approximately 200 pF is required.
- the inductance L of coil 115 and the capacitance C of capacitor 120 can be adjusted to generate a specific resonant frequency for electric circuit 110 when no blood is flowing through stent 100.
- the resonant frequency may be adjusted to match the Larmor precession frequency or resonance of the blood components (i.e. hydrogen or iron nuclei).
- electric circuit 110 resonates at a different frequency. The change in the resonant frequency of the circuit is directly proportional to the velocity of the blood flow, and thus is an indicator of that velocity.
- the progressive energy deposition at resonance is in turn shifted by the introduction of fresh blood flowing through the device.
- the energy deposition and permeability in the core of the stent are affected by the volume rate of flow in the device. Consequently, monitoring device 140 may use the calculated Q of the system to determine the volume rate of flow.
- Q the quality factor for electric circuit 110
- electric circuit 110 consists of a coil having inductance L and capacitance C. In this embodiment of the invention, electric circuit 110 does not include a lumped capacitance, but rather the capacitance is inherent in the wire implementing the coil.
- a stent 200 for enclosing a blood vessel to monitor blood flow within a vessel includes one or more microchips 220 that are powered transcutaneously.
- the chip utilizes a coil to power the device and to transmit the radiated wave.
- Microchip 220 is advantageously fabricated using CMOS technology for low power consumption, and may be fabricated using VLSI.
- Microchip 220 includes a digital memory to store pertinent information about the device (i.e. serial number, blood flows recorded, patient's name, doctor's name, ect.).
- stent 200 radiates a signal indicative of blood flow in the vessel.
- a monitoring device exterior to the patient, detects the radiated signal and reports a measure of the blood flow.
- FIG. 3 shows a stent 300 having a hollow, cylindrical shape suitable for implantation around a blood vessel.
- Stent 300 is open at both ends of the cylinder to allow blood to flow through the device.
- Component package 305 is attached to the outer wall of stent 300 for measuring blood flow and reporting the measurement transcutaneously.
- Piezoelectric crystal 310 is included in component package 305 for radiating, upon activation, the blood flow within the stent with an ultrasonic acoustic wave, and determining the rate of blood flow therefrom.
- the incident ultrasonic acoustic waves are partially reflected from the flowing blood, and the frequency of the reflected waves is altered according to the Doppler effect by an amount dependent on the blood flow velocity
- the information as to the instantaneous flow velocity is contained in the reflected acoustic waves as a modulation of the waveform radiated by piezoelectric crystal 310.
- a second piezoelectric crystal 320 is included in component package 305 to receive the reflected ultrasonic waves from the radiation transmitted by piezoelectric crystal 310.
- Piezoelectric crystal 320 radiates a radio frequency (RF) signal analogous to the reflected ultrasonic wave.
- the RF signal is detected by a monitor detector 330, exterior to the body.
- Monitor detector 330 displays blood flow information corresponding to the RF signal.
- the RF signal generated by piezoelectric crystal 320 may be amplified by an amplifier 340 to boost the strength of the signal prior to transmission by another piezoelectric crystal 350.
- Stent 300 includes a coil 360 which is used to power the active components of the stent. An electromagnetic wave is transmitted transcutaneously to stent 300 to cause a current to flow in coil 360. The current from coil 360 drives an AC/DC converter 370 to power stent 300.
- Amplifier 330, coil 360, and AC/DC converter 370 may alternatively be packaged as an integrated circuit rather than implemented using discreet components. If the components are implemented using integrated circuit technology, it may advantageous to fabricate the circuit using a CMOS implementation for lower power consumption.
- the devices of the present invention include thermal sensors and circuitry for the delivery of therapeutic heat or vibrations to the blood vessel in order to inhibit restenosis.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Electromagnetism (AREA)
- Hematology (AREA)
- Physiology (AREA)
- Cardiology (AREA)
- Computer Networks & Wireless Communication (AREA)
- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims (21)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/044,631 US6015387A (en) | 1997-03-20 | 1998-03-19 | Implantation devices for monitoring and regulating blood flow |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4117297P | 1997-03-20 | 1997-03-20 | |
US09/044,631 US6015387A (en) | 1997-03-20 | 1998-03-19 | Implantation devices for monitoring and regulating blood flow |
Publications (1)
Publication Number | Publication Date |
---|---|
US6015387A true US6015387A (en) | 2000-01-18 |
Family
ID=26717879
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US09/044,631 Expired - Fee Related US6015387A (en) | 1997-03-20 | 1998-03-19 | Implantation devices for monitoring and regulating blood flow |
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Cited By (160)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000056241A1 (en) * | 1999-03-24 | 2000-09-28 | Noveon Ip Holdings Corp. | Acoustic-based remotely interrogated diagnostic implant device and system |
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